Abbreviated New Drug Application
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA) is a written request to the U.S. Food and Drug Administration (FDA) to approve a generic drug for sale and marketing in the United States. The ANDA is submitted once the patent protection for the original drug has expired.
Pronunciation
Abbreviated: /əˈbriː.vi.eɪ.tɪd/ New: /njuː/ Drug: /drʌɡ/ Application: /ˌæp.lɪˈkeɪ.ʃən/
Etymology
The term "Abbreviated New Drug Application" is derived from the process it describes. It is an "abbreviated" version of the New Drug Application (NDA), which is a more comprehensive application for new, innovative drugs. The term "new drug" refers to the fact that the drug is a generic version of a drug that has not previously been marketed, and "application" refers to the formal request made to the FDA.
Related Terms
- Generic Drug: A medication that is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance, and intended use.
- New Drug Application (NDA): The vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.
- U.S. Food and Drug Administration (FDA): The federal agency responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal foods & feed, and veterinary products.
External links
- Medical encyclopedia article on Abbreviated New Drug Application
- Wikipedia's article - Abbreviated New Drug Application
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